Cleared Traditional

K902887 - CUSTOMED ARTHROSCOPY PACK

K902887 is an FDA 510(k) clearance for CUSTOMED ARTHROSCOPY PACK, manufactured by Customed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K902887 · Customed, Inc. · General & Plastic Surgery device
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Sep 1990
Decision
70d
Days
Class 2
Risk

K902887 is an FDA 510(k) clearance for the CUSTOMED ARTHROSCOPY PACK. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Customed, Inc. (Carolina Puerto Rico, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Customed, Inc. devices

FDA 510(k) Submission Details - K902887

510(k) Number K902887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date September 10, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 55
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K902887.
STERILE DISPOSABLE WET SKIN SCRUB TRAY
K914174 · Medical Device Inspection Co., Inc. · Feb 1992
WOUND CLOSURE KIT
K910365 · Megadyne Medical Products, Inc. · Mar 1991
MEGA LACERATION KIT
K910368 · Megadyne Medical Products, Inc. · Mar 1991
CUSTOMED ORTHOPEDIC II
K902888 · Customed, Inc. · Sep 1990
CUSTOMED HIP PACT
K903336 · Customed, Inc. · Aug 1990
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
K895202 · Transidyne General Corp. · Sep 1989